Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT) (UB ECT)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
bilateral ultrabrief ECT
bilateral standard ECT
right-unilateral ultrabrief ECT
right-unilateral standard ECT
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
- Total MADRS score >/= 25
- Age >/= 18 years
- Educated or working in an English medium setting
Exclusion Criteria:
- Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
- history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
- ECT in last 3 months
- Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
- unable to give informed consent
- score < 24 on Mini Mental State Examination
Sites / Locations
- St George Hospital
- Wandene Private Hospital
- The Melbourne Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
bilateral-ultrabrief ECT
bilateral standard ECT
right-unilateral ultrabrief ECT
right-unilateral standard ECT
Arm Description
Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.
Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.
Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.
Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.
Outcomes
Primary Outcome Measures
Change in scores on Memory Tests
Secondary Outcome Measures
Change in scores on Depression Rating Scale
Full Information
NCT ID
NCT00870805
First Posted
March 26, 2009
Last Updated
February 26, 2013
Sponsor
The University of New South Wales
Collaborators
Northside Clinic, Australia, The Melbourne Clinic, Australia, St George Hospital, Australia, Wandene Private Hospital, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00870805
Brief Title
Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
Acronym
UB ECT
Official Title
A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of New South Wales
Collaborators
Northside Clinic, Australia, The Melbourne Clinic, Australia, St George Hospital, Australia, Wandene Private Hospital, Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.
Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bilateral-ultrabrief ECT
Arm Type
Experimental
Arm Description
Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.
Arm Title
bilateral standard ECT
Arm Type
Active Comparator
Arm Description
Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.
Arm Title
right-unilateral ultrabrief ECT
Arm Type
Experimental
Arm Description
Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.
Arm Title
right-unilateral standard ECT
Arm Type
Active Comparator
Arm Description
Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.
Intervention Type
Procedure
Intervention Name(s)
bilateral ultrabrief ECT
Intervention Description
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
Intervention Type
Procedure
Intervention Name(s)
bilateral standard ECT
Intervention Description
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
Intervention Type
Procedure
Intervention Name(s)
right-unilateral ultrabrief ECT
Intervention Description
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
Intervention Type
Procedure
Intervention Name(s)
right-unilateral standard ECT
Intervention Description
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
Primary Outcome Measure Information:
Title
Change in scores on Memory Tests
Time Frame
Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
Secondary Outcome Measure Information:
Title
Change in scores on Depression Rating Scale
Time Frame
Before ECT, after each week of treatment, at the end of the ECT course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
Total MADRS score >/= 25
Age >/= 18 years
Educated or working in an English medium setting
Exclusion Criteria:
Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
ECT in last 3 months
Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
unable to give informed consent
score < 24 on Mini Mental State Examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof Isaac Schweitzer, MBBS, FRANZCP, MD
Organizational Affiliation
The Melbourne Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Wandene Private Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Melbourne Clinic
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16866758
Citation
Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. doi: 10.1080/j.1440-1614.2006.01862.x.
Results Reference
background
PubMed Identifier
17706790
Citation
Loo C, Sheehan P, Pigot M, Lyndon W. A report on mood and cognitive outcomes with right unilateral ultrabrief pulsewidth (0.3 ms) ECT and retrospective comparison with standard pulsewidth right unilateral ECT. J Affect Disord. 2007 Nov;103(1-3):277-81. doi: 10.1016/j.jad.2007.06.012. Epub 2007 Aug 16.
Results Reference
background
PubMed Identifier
18752719
Citation
Loo CK, Sainsbury K, Sheehan P, Lyndon B. A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT. Int J Neuropsychopharmacol. 2008 Nov;11(7):883-90. doi: 10.1017/S1461145708009292. Epub 2008 Aug 28.
Results Reference
background
PubMed Identifier
19756236
Citation
Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001. Erratum In: Brain Stimul. 2008 Jul;1(3):A2.
Results Reference
background
Citation
Sienaert, P., Vansteelandt, K., Demyttenaere, K., & Peuskens, J. (2006). Comparison of bifrontal and unilateral ultra-brief pulse electroconvulsive therapy for depression. European Neuropsychopharmacology, 16 (suppl 4), S28.
Results Reference
background
PubMed Identifier
31056081
Citation
Martin D, Katalinic N, Hadzi-Pavlovic D, Ingram A, Ingram N, Simpson B, McGoldrick J, Dowling N, Loo C. Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial. Psychol Med. 2020 May;50(7):1121-1128. doi: 10.1017/S0033291719000989. Epub 2019 May 2.
Results Reference
derived
PubMed Identifier
25522389
Citation
Loo CK, Katalinic N, Smith DJ, Ingram A, Dowling N, Martin D, Addison K, Hadzi-Pavlovic D, Simpson B, Schweitzer I. A randomized controlled trial of brief and ultrabrief pulse right unilateral electroconvulsive therapy. Int J Neuropsychopharmacol. 2014 Dec 5;18(1):pyu045. doi: 10.1093/ijnp/pyu045. Erratum In: Int J Neuropsychopharmacol. 2016 Apr 27;:
Results Reference
derived
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Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
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